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BioPharmaceutical Business Intelligence

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  • Identify first generic entrants
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Serving leading biopharmaceutical companies globally:

Healthtrust
Daiichi Sankyo
Julphar
Citi
QuintilesIMS
Queensland Health
Medtronic
Accenture
Johnson and Johnson
Moodys

Generated: November 21, 2017

DrugPatentWatch Database Preview

Santarus Company Profile

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What is the competitive landscape for SANTARUS, and what generic alternatives to SANTARUS drugs are available?

SANTARUS has six approved drugs.

There are seventeen US patents protecting SANTARUS drugs.

There are one hundred and fifty-six patent family members on SANTARUS drugs in twenty-six countries and forty-four supplementary protection certificates in twelve countries.

Summary for Santarus

International Patents:156
US Patents:17
Tradenames:4
Ingredients:4
NDAs:6
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-002Dec 4, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Santarus Inc
FENOGLIDE
fenofibrate
TABLET;ORAL022118-002Aug 10, 2007ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 2006ABRXYesYes► Subscribe► Subscribe ► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005AB3RXYesNo► Subscribe► SubscribeYY ► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► Subscribe ► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005AB3RXYesNo► Subscribe► SubscribeYY ► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 2006DISCNNoNo► Subscribe► Subscribe ► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005AB3RXYesNo► Subscribe► SubscribeYY ► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-001Mar 24, 2006DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Santarus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-001Feb 27, 2006► Subscribe► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-001Dec 4, 2009► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 2006► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 2006► Subscribe► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-001Mar 24, 2006► Subscribe► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-001Feb 27, 2006► Subscribe► Subscribe
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Paragraph IV activity for SANTARUS drugs

Drugname Dosage Strength Tradename Submissiondate
fenofibrate
Tablets40 mg and 120 mg
FENOGLIDE
3/17/2010
metformin hydrochloride
Extended-release Tablets500 mg and 1000 mg
GLUMETZA
7/27/2009
omeprazole and sodium bicarbonate
Powder for Oral Suspension20mg/1680mg per packet
ZEGERID
11/13/2007
omeprazole and sodium bicarbonate
Powder for Oral Suspension40 mg/1680 mg per packet
ZEGERID
8/24/2007
omeprazole and sodium bicarbonate
Capsules20 mg/1100 mg and 40 mg/1100 mg
ZEGERID
4/30/2007

Non-Orange Book Patents for Santarus

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,772,273Stabilized atorvastatin► Subscribe
8,158,147Modified release formulations of at least one form of tramadol► Subscribe
8,128,957Modified release compositions of at least one form of tramadol► Subscribe
2,005,182,056► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Santarus Drugs

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2006037344► Subscribe
Israel153464► Subscribe
Japan5069395► Subscribe
Spain2275650► Subscribe
MexicoPA04008164► Subscribe
World Intellectual Property Organization (WIPO)03035177► Subscribe
Norway20023313► Subscribe
MexicoPA02006780► Subscribe
Austria256455► Subscribe
Japan2005519901► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Santarus Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
9 5017-2014Slovakia► SubscribePRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
00517Netherlands► SubscribePRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2008000046Germany► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
C/GB08/040United Kingdom► SubscribePRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
00482Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
00357Netherlands► SubscribePRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2014000070Germany► SubscribePRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice
Mallinckrodt
Chubb
Baxter
Moodys
McKinsey
Johnson and Johnson
Farmers Insurance
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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